BioMonitor

Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Biomonitor.

Pre-market Notification Details

• Device ID: K143503
• 510k Number: K143503
• Device Name: BioMonitor
• Classification: Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
• Applicant: BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035
• Contact: Jon Brumbaugh
• Correspondent: Jon Brumbaugh; BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035
• Product Code: MXD
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-10
• Decision Date: 2015-03-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04035479131210	K143503	000